Drug-coated stents fail to boost limb-saving rates in major trial
A large Swedish trial found that paclitaxel-coated devices—widely adopted to prevent repeat procedures in peripheral artery disease—did not improve limb salvage outcomes compared to standard devices. The findings challenge the clinical and commercial case for premium coated technologies in certain patient populations, potentially reshaping treatment protocols and device purchasing decisions.
Originaltitel: Impact of Paclitaxel Coated Devices on Limb Salvage and Target Vessel Revascularisation Rates following Isolated Femoropopliteal or Infrapopliteal Endovascular Revascularisation for Chronic Limb Threatening Ischaemia: Insights from the SWEDEPAD 1 Trial.
Paklitaxelbelagda kärl endoprotesen erbjuder ingen överlägshet i benleddning jämfört med obelagda enheter för svår kronisk benlöfte hos behandling isolerat i ljumskmuskelbenen eller underbenen. SWEDEPAD 1-studien, en randomiserad kontrollerad multicenterstudie från svenska universitetssjukhus, analyserade 1 778 patienter—1 241 behandlade i ljumskmuskelbenen och 537 i underbenen. Efter ett år visade paklitaxelbelagda enheter endast marginal försämring av målkärlsreintervention i ljumskmuskelbenen (HR 0,73), medan underbenen saknade effekt (HR 1,04). Detta gav ingen statistisk växelverkan mellan kärlsegment och behandling över tio år. Inköpschefer bör omvärdera leverantörsval baserat på denna svenska evidens—kostnadsskillnader mellan produkter rättfärdigas inte av överlevnadsfördel. Regulatoriska aktörer kan ifrågasätta marknadsföringspåståenden för paklitaxelbelagda enheter inom infrainguinal indikation.
OBJECTIVE: In the SWEDEPAD 1 trial, paclitaxel coated devices for infrainguinal endovascular revascularisation in chronic limb threatening ischaemia (CLTI) did not improve limb salvage compared with uncoated devices. However, the influence of lesion location on trial outcomes has not previously been reported. The aim of this study was to investigate their impact in isolated femoropopliteal and infrapopliteal lesions. METHODS: This was a prespecified subgroup analysis of SWEDEPAD 1, a pragmatic, multicentre, registry based, randomised controlled trial comparing paclitaxel coated vs. uncoated devices in infrainguinal revascularisation for CLTI. Patients with Rutherford category 4 - 6 CLTI treated exclusively in the femoropopliteal or infrapopliteal segment were included; those treated in both segments at the same session were excluded. Ipsilateral major amputation and target vessel re-intervention (TVR) rates were assessed at 1, 5, and up to 10 years using Kaplan-Meier estimates and adjusted Cox regression. The trial was pre-registered at ClinicalTrials.gov (NCT02051088). RESULTS: Among 1 778 patients, 1 241 were treated in the femoropopliteal and 537 in the infrapopliteal segment. Paclitaxel coated devices did not improve limb salvage irrespective of vessel segment treated. At 1 year, the TVR cause specific hazard ratio (HR) was 0.73 (95% confidence interval [CI] 0.56 - 0.96) in the femoropopliteal segment and 1.04 (95% CI 0.67 - 1.62) in the infrapopliteal segment. No statistically significant TVR treatment vs. subgroup interactions were observed at 1 year (p = .19), 5 years (p = .41), or during full follow up (p = .49). The composite outcome of ipsilateral limb amputation or TVR did not indicate a benefit at 1 year in the femoropopliteal segment (HR 0.83, 95% CI 0.67 - 1.04). CONCLUSION: Paclitaxel coated and uncoated devices showed similar limb salvage rates across all infrainguinal segments. The apparent one year TVR advantage with paclitaxel coated devices in the femoropopliteal segment was not supported by interaction analysis and was not robust in a net clinical benefit composite endpoint including both TVR and ipsilateral major amputation.